Sartorius Sartoclear 29XDL10-FCFFF Directions For Use

Directions for Use
Sartoclear Depth Filter 0.08 m² Midscale Cassette
®
1. Introduction
The purpose of this document is to outline the
appropriate method for installing and using the
laboratory scale device of Sartoclear
0.08 m² midscale cassette.
2. Liability
The products described in this document are intended
to be used for the clarification of mammalian and
microbial cell cultures. Sartorius shall not assume any
liability if Sartoclear Depth Filter products have been
®
subjected to improper use. The use of this product for
any other applications or in another manner than
described in this manual may result personal injury or
malfunction of the product. Please follow the
instructions in this user manual to ensure your own
safety and to obtain optimal filtration results. In the
interest of product development, we reserve the right
to make changes.
3. Identification
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This document pertains to Sartorius Stedim Biotech
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Sartoclear Depth Filter 0.08 m² cassette with the
®
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following part numbers:
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29XDL10-FCFFF
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29XDL20-FCFFF
29XDL60-FCFFF
29XDL75-FCFFF
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29XDL90-FCFFF
Connector types:
FF – ¾" Sanitary Flange
4. Wetting of a Sartoclear
®
midscale cassette
Sartoclear Depth Filter 0.08 m² midscale cassette
®
must be flushed with WFI in order to remove air and
water soluble compounds originating from the raw
materials. For detailed extractable profiles please refer
to the validation guide: DIR code: 2632689
Fill the cassette with WFI with both vent valves on side
left open. Close both vent valves as soon as fluid flows
through the vent valves and start the flushing process.
Flushing volumes
In order to remove all air from the cassette it is
recommended to flush the cassette with at least
50 L/m² WFI (4 Liter per cassette).
Depth Filter
®
Depth Filter 0.08 m²
Flushing rates
In order to remove all air from the cassette it is
recommended to use flow rates of max. 150 l/m²/h.
The flow rate during flushing should be 25% faster
than the flowrate used for filtration.
Prior filtration the remaining flushing liquid inside the
filter can be removed by using 0.4 bar pressurized air
to avoid dilution of the filtrate (see also Recovery
Optimization). Once Sartoclear
midscale cassette are completely drained, both drain-
age valves should be closed. The cassette is now ready
for the filtration process. It is recommended to vent
-
again before filtration.
5. Filtration
Start the Sartoclear Depth Filter 0.08 m² midscale
®
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cassette filtration with a flow rate between
80 – 200 L/ m /h. (For most applications lower flow
2
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rates give better throughputs per m²)
Close the vents on the IN- and OUTLET when the
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housings are filled (fluid will appear in the tube)
Continue filtration until a pressure of maximal 1.5 bar
(21.75 psi) is reached.
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NOTE: For an optimal recovery of your product it
is recommended to stop the filtration at 1.0 bar
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(14.5 PSI) (see also: Recovery optimization)
The maximum operating pressure during filtration is
1.7 bar (24.7 psi)
The temperature of the fluid must be between
5 – 40° C
Pressure
control
Peristaltic
Mixing pump
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6. Recovery optimization
Connect a container with a suitable buffer for your
-
application to the filtration set up
Start flushing the system with constant flow or
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constant pressure
Best results were obtained with 20 L per m² depth
filter and a maximum pressure of 1.0 bar (14.5 psi)
Alternative Option: In order to avoid product dilution
pressurized air (max. 0.4 bar) can be used to empty
the filters (see below: B1 Draining of the system)
Depth Filter 0.08 m²
®
Sartoclear Weight
module control